Following the recent incident of counterfeit Crestor, the TFDA made an advance announcement on Friday (21st) in order to prevent similar incidents from happening. According to the advance announcement, the TFDA is going to introduce a measure for controlling the 20 most popular drugs reimbursed by the NHI as soon as from the end of this yea. A maximum fine of NT$2 million could be imposed on those who fail to follow the regulation.
The pharmaceutical track-and-trace system took effect from July 1st. Preliminarily, it applies only to blood preparations, vaccines and botulinum toxin products. This advance announcement is about the TFDA’s intention to revise Article 6-1 of the Pharmaceutical Affairs Law concerning the drug categories subject to the track-and-trace system. The TFDA intends to include the 20 most popular drugs reimbursed by the NHI into the application scope.
Huang Cin-Liang, an official of the TFDA, expressed that the TFDA has been piloting the track-and-trace system on the 20 most popular drugs reimbursed by the NHI since April. The track-and-trace system is effective in preventing counterfeit drugs from entering the market. Furthermore, in the situation of a counterfeit event, the system is able to quickly monitor the flow of authentic and counterfeit drugs and hasten the call-back process.
So far, the TFDA has already received reports from the license holders of the 20 drugs. However, the communication with downstream suppliers is still in progress, said Huang.
Huang Cin-Liang pointed out that the draft revision of Article 6-1is now in the 60-day commenting period. The TFDA will collect opinions from stakeholders, and aim to introduce the law by the end of this year. Once the regulation is in practice, companies who fail to report to the system will receive a fine of NT$30,000-2 million. The TFDA is going to promote the track-and-trace system along with the GDP Guidelines with a view to keeping counterfeit drugs out of the supply chain.
【2017-07-21 / Central News Agency】